Effects of Exercise Training and Ketone Ester on Muscle Strength and Cardiovascular Response in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Dietary Supplement: Electrolyte Beverage; Dietary Supplement: Ketone Ester Beverage; Behavioral: Cycling Intervention

• Registration Number: NCT05948956
• Lead Sponsor: University of Michigan

Brief Summary

The main purpose of this study is to assess changes in exercise capacity in people with Parkinson's disease before and after an exercise training program with ketone ester supplementation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-17
• Study Start: 2023-07-28
• Primary Completion: 2025-03-21
• Study Completion: 2025-03-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of Parkinson's Disease

Exclusion Criteria

• Any recent changes in EKG, history of myocardial infarction or other cardiac event or other cardiac contraindications to exercise
• Inability to use a step, stand, walk, or use a stationary cycle ergometer
• History of symptoms in exercise that preclude safe and comfortable participation, such as dizziness and lightheadedness, orthostasis, severe symptomatic leg or back musculoskeletal pain, painful neuropathy, significant ankle edema or medication side effects
• History of symptomatic cardiovascular or pulmonary disease interfering with exercise
• History of active rheumatoid arthritis
• History of uncontrolled chronic pain syndrome
• Any other history of medical or psychiatric comorbidity precluding safe participation in the project
• Poorly controlled diabetes
• Pregnancy or breastfeeding
• Clinically significant dementia
• Any contraindications to MRI (metal implants, severe claustrophobia, inability to lie still for 1 hour, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrolyte Beverage & Exercise	Electrolyte Beverage	Participants will consume placebo electrolyte (EL) beverage, consisting of an electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise
Electrolyte Beverage & Exercise	Cycling Intervention	Participants will consume placebo electrolyte (EL) beverage, consisting of an electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise
Ketone Ester Beverage & Exercise	Ketone Ester Beverage	Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Juvenescence Cognitive Switch ™ and electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise.
Ketone Ester Beverage & Exercise	Cycling Intervention	Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Juvenescence Cognitive Switch ™ and electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise.

Primary Outcome Measures

Name	Time	Method
Change in duration of 80 rpm endurance test	After approximately 2-6 weeks of intervention	Participants will cycle at their personalized fixed wattage at 80 rpm until failure, defined as the point at which the participant could not sustain a cadence of \>70 rpm for a cumulative total of 20 s, or until voluntarily choosing to end the test. Change in duration will be calculated by subtracting the baseline duration from duration at follow-up. Greater duration indicates better endurance.
Change in oxygen uptake (VO2 max)	After approximately 2-6 weeks of intervention	VO2 max (defined as volume of oxygen consumed in mL divided by body weight in kg per minute) will be measured during a controlled cycling session on a stationary bike. Participants will begin at a cadence of 80 rpm at 50 watts for 4 minutes. Thereafter, wattage will increase by 10 watts every 2 minutes until the participant voluntarily ends the session or is no longer able to sustain a cadence of \>70 rpm. Participants will wear a face mask that measures their oxygen intake during the session. Change in VO2 max will be calculated by subtracting the baseline VO2 max from VO2 max at follow-up. Greater VO2 max indicates better cardiorespiratory fitness.

Trial Locations

Locations (1)

Domino's Farms; 🇺🇸 Ann Arbor, Michigan, United States